Recently, we have been receiving a number of indications regarding MDRs (adverse event reports).
Adverse event (incident) reports to the FDA must be submitted within a specified time frame.

We have prepared a sample report for medical device companies that are planning to prepare an adverse event report, companies that are scheduled for an FDA inspection, and companies that have received an improvement order from the FDA.
The sample is in MS-Word format, so your company can freely add to or modify it as you wish.

List of Forms
The following forms are included with your purchase.
MD-QMS-S8301 MDR Procedure

Table of Contents

Procedure

1 PURPOSE
2 SCOPE
3 Definition of terms
4 Role and Responsibility
4.1 Judgement of necessity of MDR reports
4.2 Types of report
4.3 Report to FDA
5 MDR files
5.1 Contents of MDR files
5.2 Storage place of MDR files
5.3 Storage term of MDR files
6 Reference
7 Appendices